Then there’s the pesky issue of how to calculate the sales price to determine the taxes due. IRS Notice 2012-77 notes 5 different scenarios for calculating sales price. Which one applies to you?

In addition, the IRS has the right to audit and expects you to be able to justify your eligibility and exemption choices — and provide documented evidence to back up your stance. Are you ready?

The Medical Device Excise Tax has been one of the most controversial policies to affect the industry in decades. But the pain can be mitigated if you properly apply the exemptions provided and document your actions. FDAnews, in conjunction with medical device tax expert Dan Lynn, has created your personal pain management plan. In just 90 minutes, Mr. Lynn walks listeners through each element of the tax calculation. He guides you through 6 major questions everyone is asking:

What companies are subject to the tax and why?

How does the IRS determine what’s a taxable product and what’s not — some of the answers will surprise you!

Exemptions, exemptions, exemptions! How can I legally exempt various products from the tax?

If my products do apply, how do I determine the constructive sales price and when should I use it? Underpaying this tax is definitely not recommended.

Avoiding compliance woes — have I properly registered my company and product lines, what about selling to “sister” companies, or where do I send the money and how?

What about quirky stuff like combination products and kitting/convenience kits — what’s up with them?

Medical Device Excise Tax audio CD/Transcript listeners will:

Develop a basic understanding of the tax, with myths about the tax being debunked

Determine if your company is subject to the tax

Understand the 7 triggers that subject a company to the tax

Learn best practices and suggested models for evaluating your products for inclusion/exclusive of tax eligibility

Be able to determine if the retail exemption or facts and circumstances tests apply to your products

Be confident in your understanding of the OTC exemption; including applying the FDA’s online IVD Home Use Lab Tests database or device registration and listing database

Determine if the IRS considers your product a DMEPOS and can you exempt yourself

This audio CD/Transcript is a must for professionals in the device industry, including:

Medical device manufacturing and executives

US importers of medical devices

Regulatory affairs and compliance professionals

Strategic planning and business development staff

Financial accountants and support staff

Engineering executives

Dan Lynn is a CPA, MBA, Tax Partner at Beene Garter. Mr. Lynn offers more than 20 years of experience working with medical device manufacturers and importers. He has specialized knowledge in the areas of manufacturing and distribution, as well as continuing care retirement communities. His areas of expertise include mergers and acquisitions, business transition, accounting methods and tax transactional consulting. He also has experience in tax due diligence, FAS 109, consolidated corporations and the taxation of partnerships, S corporations and trusts. Mr. Lynn earned his Bachelor of Arts Degree and his Master of Business Administration in Accounting from Michigan State University. He currently serves as an adjunct professor of taxation at Grand Valley State University, and also serves on their MST and MSA Advisory Panels. His professional memberships include the American Institute of Certified Public Accountants (AICPA), the Michigan Association of Certified Public Accountants (MACPA) and the Association for Corporate Growth (ACG).